§ 273. Organ procurement organizations

§ 273. Organ procurement organizations

(a) Grant authority of Secretary

(1) The Secretary may make grants for the planning of qualified organ procurement organizations described in subsection (b).

(2) The Secretary may make grants for the establishment, initial operation, consolidation, and expansion of qualified organ procurement organizations described in subsection (b).

(b) Qualified organizations

(1) A qualified organ procurement organization for which grants may be made under subsection (a) is an organization which, as determined by the Secretary, will carry out the functions described in paragraph (2) 11 See References in Text note below. and—

(A) is a nonprofit entity,

(B) has accounting and other fiscal procedures (as specified by the Secretary) necessary to assure the fiscal stability of the organization,

(C) has an agreement with the Secretary to be reimbursed under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] for the procurement of kidneys,

(D) notwithstanding any other provision of law, has met the other requirements of this section and has been certified or recertified by the Secretary within the previous 4-year period as meeting the performance standards to be a qualified organ procurement organization through a process that either—

(i) granted certification or recertification within such 4-year period with such certification or recertification in effect as of January 1, 2000, and remaining in effect through the earlier of—

(I) January 1, 2002; or

(II) the completion of recertification under the requirements of clause (ii); or

(ii) is defined through regulations that are promulgated by the Secretary by not later than January 1, 2002, that—

(I) require recertifications of qualified organ procurement organizations not more frequently than once every 4 years;

(II) rely on outcome and process performance measures that are based on empirical evidence, obtained through reasonable efforts, of organ donor potential and other related factors in each service area of qualified organ procurement organizations;

(III) use multiple outcome measures as part of the certification process; and

(IV) provide for a qualified organ procurement organization to appeal a decertification to the Secretary on substantive and procedural grounds; 22 So in original. The semicolon probably should be a comma.

(E) has procedures to obtain payment for non-renal organs provided to transplant centers,

(F) has a defined service area that is of sufficient size to assure maximum effectiveness in the procurement and equitable distribution of organs, and that either includes an entire metropolitan statistical area (as specified by the Director of the Office of Management and Budget) or does not include any part of the area,

(G) has a director and such other staff, including the organ donation coordinators and organ procurement specialists necessary to effectively obtain organs from donors in its service area, and

(H) has a board of directors or an advisory board which—

(i) is composed of—

(I) members who represent hospital administrators, intensive care or emergency room personnel, tissue banks, and voluntary health associations in its service area,

(II) members who represent the public residing in such area,

(III) a physician with knowledge, experience, or skill in the field of histocompatibility or an individual with a doctorate degree in a biological science with knowledge, experience, or skill in the field of histocompatibility,

(IV) a physician with knowledge or skill in the field of neurology, and

(V) from each transplant center in its service area which has arrangements described in paragraph (3)(G) with the organization, a member who is a surgeon who has practicing privileges in such center and who performs organ transplant surgery,

(ii) has the authority to recommend policies for the procurement of organs and the other functions described in paragraph (3), and

(iii) has no authority over any other activity of the organization.

(2)

(A) Not later than 90 days after November 16, 1990, the Secretary shall publish in the Federal Register a notice of proposed rulemaking to establish criteria for determining whether an entity meets the requirement established in paragraph (1)(E).^1

(B) Not later than 1 year after November 16, 1990, the Secretary shall publish in the Federal Register a final rule to establish the criteria described in subparagraph (A).

(3) An organ procurement organization shall—

(A) have effective agreements, to identify potential organ donors, with a substantial majority of the hospitals and other health care entities in its service area which have facilities for organ donations,

(B) conduct and participate in systematic efforts, including professional education, to acquire all useable organs from potential donors,

(C) arrange for the acquisition and preservation of donated organs and provide quality standards for the acquisition of organs which are consistent with the standards adopted by the Organ Procurement and Transplantation Network under section 274(b)(2)(E) of this title, including arranging for testing with respect to identifying organs that are infected with human immunodeficiency virus (HIV),

(D) arrange for the appropriate tissue typing of donated organs,

(E) have a system to allocate donated organs equitably among transplant patients according to established medical criteria,

(F) provide or arrange for the transportation of donated organs to transplant centers,

(G) have arrangements to coordinate its activities with transplant centers in its service area,

(H) participate in the Organ Procurement Transplantation Network established under section 274 of this title,

(I) have arrangements to cooperate with tissue banks for the retrieval, processing, preservation, storage, and distribution of tissues as may be appropriate to assure that all useable tissues are obtained from potential donors,

(J) evaluate annually the effectiveness of the organization in acquiring potentially available organs, and

(K) assist hospitals in establishing and implementing protocols for making routine inquiries about organ donations by potential donors.

(c) Pancreata islet cell transplantation or research Pancreata procured by an organ procurement organization and used for islet cell transplantation or research shall be counted for purposes of certification or recertification under subsection (b).

(July 1, 1944, ch. 373, title III, § 371, as added Pub. L. 98–507, title II, § 201, Oct. 19, 1984, 98 Stat. 2342; amended Pub. L. 100–607, title IV, § 402(a), (c)(1), (2), (d), Nov. 4, 1988, 102 Stat. 3114, 3115; Pub. L. 101–616, title II, §§ 201(a)–(c)(1), (d), (e), 206(b), Nov. 16, 1990, 104 Stat. 3283, 3285; Pub. L. 106–505, title VII, § 701(c), Nov. 13, 2000, 114 Stat. 2347; Pub. L. 106–554, § 1(a)(1) [title II, § 219(b)], Dec. 21, 2000, 114 Stat. 2763, 2763A–29; Pub. L. 108–216, § 9, Apr. 5, 2004, 118 Stat. 590; Pub. L. 108–362, § 2, Oct. 25, 2004, 118 Stat. 1703; Pub. L. 113–51, § 2(a)(2), (3), Nov. 21, 2013, 127 Stat. 579, 580; Pub. L. 118–14, § 3(1), Sept. 22, 2023, 137 Stat. 69.)

Editorial Notes

References in Text

Paragraph (2), referred to in subsec. (b)(1), meaning paragraph (2) of subsec. (b) of this section, was redesignated paragraph (3) by section 201(d)(1) of Pub. L. 101–616. See 1990 Amendment note below.

The Social Security Act, referred to in subsec. (b)(1)(C), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Title XVIII of the Social Security Act is classified generally to subchapter XVIII (§ 1395 et seq.) of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables.

Paragraph (1)(E), referred to in subsec. (b)(2)(A), meaning par. (1)(E) of subsec. (b) of this section, probably should refer to par. (1)(F) of subsec. (b) after the redesignations by section 701(c)(1) of Pub. L. 106–505, section 1(a)(1) [title II, § 219(b)(1)] of Pub. L. 106–554, and section 2(a)(3)(B) of Pub. L. 113–51, which successively redesignated such subpar. (E) as (F), (G), and (F). See 2000 and 2013 Amendment notes below.

Prior Provisions

A prior section 273, act July 1, 1944, ch. 373, title III, § 371, as added July 28, 1956, ch. 772, title II, § 201, 70 Stat. 709, authorized grants to the Territory of Alaska for an integrated mental health program, prior to repeal by Pub. L. 86–70, § 31(b)(1), June 25, 1959, 73 Stat. 148, effective July 1, 1959.

A prior section 371 of act July 1, 1944, added by act Aug. 3, 1956, ch. 907, § 1, 70 Stat. 960, was renumbered section 381 and classified to section 275 of this title, prior to repeal by Pub. L. 99–158, § 3(b), Nov. 20, 1985, 99 Stat. 879.

Amendments

2023—Subsec. (b)(1)(H)(i)(III). Pub. L. 118–14 substituted “histocompatibility or an individual” for “histocompatability or an individual”.

2013—Subsec. (b)(1)(E), (F). Pub. L. 113–51, § 2(a)(3)(A), (B), redesignated subpars. (F) and (G) as (E) and (F), respectively, and struck out former subpar. (E) which was identical to subpar. (D).

Subsec. (b)(1)(G). Pub. L. 113–51, § 2(a)(3)(C), substituted “(G) has a director” for “(H) has a director”. Former subpar. (G) redesignated (F).

Subsec. (b)(1)(H)(i)(V). Pub. L. 113–51, § 2(a)(3)(D)(i), substituted “paragraph (3)(G)” for “paragraph (2)(G)”.

Subsec. (b)(1)(H)(ii). Pub. L. 113–51, § 2(a)(3)(D)(ii), substituted “paragraph (3)” for “paragraph (2)”.

Subsec. (b)(3)(C). Pub. L. 113–51, § 2(a)(2), substituted “including arranging for testing with respect to identifying organs that are infected with human immunodeficiency virus (HIV)” for “including arranging for testing with respect to preventing the acquisition of organs that are infected with the etiologic agent for acquired immune deficiency syndrome”.

2004—Subsec. (a)(3). Pub. L. 108–216 struck out par. (3) which read as follows: “The Secretary may make grants to, and enter into contracts with, qualified organ procurement organizations described in subsection (b) of this section and other nonprofit private entities for the purpose of carrying out special projects designed to increase the number of organ donors.”

Subsec. (c). Pub. L. 108–362 added subsec. (c).

2000—Subsec. (b)(1)(D) to (H). Pub. L. 106–554 added subpar. (D) identical to that added by Pub. L. 106–505 and redesignated former subpars. (D) to (G), respectively, as (E) to (G) and (H) relating to director and such other staff obtaining organs from donors in its service area. Additional amendment directing realignment of margin of subpar. (F) could not be executed after amendment by Pub. L. 106–505.

Pub. L. 106–505 added subpar. (D), redesignated former subpars. (D) to (G), respectively, as (E) to (G) and (H) relating to board of directors or advisory board, and realigned margin of subpar. (F).

1990—Pub. L. 101–616, § 201(a), substituted “Organ procurement organizations” for “Assistance for organ procurement organizations” in section catchline.

Subsec. (a)(3). Pub. L. 101–616, § 201(b)(1), substituted “may make grants to, and enter into contracts with, qualified organ procurement organizations described in subsection (b) of this section and other nonprofit private entities for the purpose of carrying out special projects” for “may make grants for special projects”.

Subsec. (a)(4). Pub. L. 101–616, § 201(b)(2), struck out par. (4) which set forth factors to consider in making grants.

Subsec. (b)(1)(E). Pub. L. 101–616, § 201(c)(1), amended subpar. (E) generally. Prior to amendment, subpar. (E) read as follows: “has a defined service area which is a geographical area of sufficient size such that (unless the service area comprises an entire State) the organization can reasonably expect to procure organs from not less than 50 donors each year and which either includes an entire standard metropolitan statistical area (as specified by the Office of Management and Budget) or does not include any part of such an area,”.

Subsec. (b)(1)(G)(i)(III). Pub. L. 101–616, § 201(e), made technical correction to Pub. L. 100–607, § 402(c)(2). See 1988 Amendment note below.

Subsec. (b)(2), (3). Pub. L. 101–616, § 201(d), added par. (2) and redesignated former par. (2) as (3).

Subsec. (c). Pub. L. 101–616, § 206(b), struck out subsec. (c) which authorized appropriations for subsec. (a) grants for fiscal years 1988 through 1990.

1988—Subsec. (a)(2). Pub. L. 100–607, § 402(a)(1), inserted “consolidation,” after “initial operation,”.

Subsec. (a)(3). Pub. L. 100–607, § 402(a)(2), added par. (3). Former par. (3) redesignated (4).

Subsec. (a)(4). Pub. L. 100–607, § 402(a)(2), redesignated former par. (3) as (4).

Subsec. (a)(4)(C). Pub. L. 100–607, § 402(a)(3), added subpar. (C).

Subsec. (b)(1)(E). Pub. L. 100–607, § 402(c)(1)(A), substituted “size such that” for “size which”, and “the organization can reasonably expect to procure organs from not less than 50 donors each year” for “will include at least fifty potential organ donors each year”.

Subsec. (b)(1)(G)(i)(III). Pub. L. 100–607, § 402(c)(2), as amended by Pub. L. 101–616, § 201(e), inserted “or an individual with a doctorate degree in a biological science with knowledge, experience, or skill in the field of histocompatibility” before comma at end.

Subsec. (b)(2)(C). Pub. L. 100–607, § 402(c)(1)(B), substituted “274(b)(2)(E) of this title, including arranging for testing with respect to preventing the acquisition of organs that are infected with the etiologic agent for acquired immune deficiency syndrome,” for “274(b)(2)(D) of this title,”.

Subsec. (b)(2)(E). Pub. L. 100–607, § 402(c)(1)(C), substituted “organs equitably among transplant patients” for “organs among transplant centers and patients”.

Subsec. (b)(2)(K). Pub. L. 100–607, § 402(c)(1)(D), added subpar. (K).

Subsec. (c). Pub. L. 100–607, § 402(d), amended subsec. (c) generally. Prior to amendment, subsec. (c) read as follows: “For grants under subsection (a) of this section there are authorized to be appropriated $5,000,000 for fiscal year 1985, $8,000,000 for fiscal year 1986, and $12,000,000 for fiscal year 1987.”

Statutory Notes and Related Subsidiaries

Effective Date of 1990 Amendment

Pub. L. 101–616, title II, § 207, Nov. 16, 1990, 104 Stat. 3286, provided that: “Except as otherwise provided in this title, the amendments made by this title [enacting sections 274f and 274g of this title, amending this section and sections 274 and 274b to 274d of this title, and repealing provisions set out as a note below] shall become effective on October 1, 1990, or on the date of the enactment of this Act [Nov. 16, 1990], whichever occurs later.”

Effective Date of 1988 Amendment